S1316 – The Malignant Bowel Obstruction Study A Prospective Comparative Effectiveness Trial for...

S1316 – The Malignant Bowel Obstruction StudyA Prospective Comparative Effectiveness Trial for

Malignant Bowel Obstruction

• SWOG Study Chairs:

Robert S. Krouse, M.D., SAVAHCS/University of Arizona, Surgical Oncology

Brian Badgwell, M.D., MD Anderson Cancer Center

• Alliance Investigator:

Amy Abernethy, M.D., Duke University Medical Center

• Nurse Chair:

Virginia Sun, R.N., Ph.D., City of Hope

S1316 - MBO Professional Slide Set, Version 01

S1316JACS Paper on MBO

•Aggressive non-surgical palliative care options can help avoid an operation

•There are many clinical scenarios when an operation is unlikely to benefit MBO patients

•Can we test which treatment strategy (surgery vs. “aggressive” palliative management) is optimal in MBO?


S1316- MBO Study Aims

To assess the quality of life outcome of the number of days alive and outside of the hospital within the first 91 days (13 weeks) after registration, for patients with malignant bowel obstruction who receive surgical intervention as compared to non-surgical intervention.

Research Questions:

• Are there differences in HRQOL outcomes for patients with MBO who receive surgical intervention as compared to non-surgical intervention?

• Are there clinical factors that predict better HRQOL outcomes for patients with MBO who receive surgical or non-surgical intervention?


S1316 – MBO StudyPrimary Endpoint

“Good days” = days out of the hospital and alive in the first 91 days (13 weeks) after registration Secondary Endpoints• Days with NG tube• Days eating (Diet recalls)• HRQOL (MDASI-GI, EQ-5D-5L) • Morbidity/Mortality• Survival



S1316 Study Timeline

2014 2015 2016

Study accrues

2017 2018

Study closes

to accrual

Prepare for study activation

Training

Obtain IRB approvals

2019

Study data complete and

submitted

• Complete data clean-up• Analyze data for primary

endpoint• Prepare abstract• Write and publish primary

paper

Work on secondary analyses

2020

S1316 - MBO Study Schema


Meets all eligibility requirements (N=180)

Consents to randomization (N=50)

Consents to non-randomized treatment(N=130)

Surgery (50%) (Arm 1)

Non-surgical management (50%) (Arm 2)

Surgery (Arm 3)

Non-surgical management (Arm 4)

All patients will be followed for 53 weeks.


S1316 Patient Timeline

Hospitalization with MBO

Week 53

Follow-up Complete

Day 0Registration

Week 13

Data for primary endpoint reported

• Site calls patient every 4 weeks for assessments

• Patient has dietary recall every 4 weeks

• Report all hospitalizations• Site calls patient weekly for

assessments• Patient has dietary recall every

4 weeks

S1316 - MBO StudyAccrual Goal

• Study will accrue 180 eligible patients

• Study expects to accrue over 3 years

• Two study components

– Randomization component (n=50)– Non-randomized component (n=130)


S1316 – MBO StudyEligibility Criteria

• MBO due to intra-abdominal cancer

• Admission to hospital

• Surgical candidate (would tolerate an operation and indication for surgery)

• Performance status (Zubrod Performance Status of 0 - 2 one week prior to admission)

• Able to complete questionnaires in English


S1316 – MBO StudyIneligibility Criteria (cont’d)

• MBO not due to intra-abdominal cancer

• Patient actively dying

• Patient requires an emergency surgical procedure, e.g., acute abdomen

• Patient refuses to allow study staff to contact him/her for study follow-up


S1316 – MBO StudyTimeline for Initial Patient Care


Time from initial surgical consult to start of treatment should not be more than a week.

Treatment may begin on the same day as the surgical consult as long as the order of events is preserved (surgical consult first, then registration, then treatment).

Treatment must begin after registration. Patients for whom treatment is initiated prior to registration are ineligible.

Up to 3 working days Up to 2 working days

|----------------------------|---------------------------|Surgical Consult or admission to Surgical Service

Register to S1316 Begin Treatment

S1316 – MBO StudyInitial Data Submission

• Baseline data– Onstudy, MDASI-GI, EQ-5D-5L

• MBO treatment and complications data for initial hospitalization

• Pathology report to confirm primary cancer

• Radiology reports to confirm MBO


S1316 – MBO StudyFollow-Up

• Weekly phone assessments and data collection by study site staff for first 13 weeks and every 4 weeks thereafter up to one year

• Dietary recall phone calls every 4 weeks up to one year

• MBO treatment and complications data for all hospitalizations in first 13 weeks


S1316 – MBO StudyDietary Recall

• Self-reported diet measurement methods

• Relies on patient or caregiver to report foods consumed in prior 24-hour period

• Collected by Arizona Diet, Behavior, Quality of Life Assessment Lab through phone contact


S1316 – MBO StudyCriteria for Removal from Protocol Follow-up

• Completion of 53 weeks on study• Medical condition that the treating

investigator believes precludes continued participation

• Patient refusal for any reason, including discontinuation of weekly phone calls

All reasons for discontinuation of follow-up will be documented but hospitalization data and vital status will still be reported.


S1316 – MBO Study Analysis Plan

Study includes two components: randomized (n=50) and non-randomized (n=130)

Inference will be based on assigned treatment• Randomized component will use

randomized treatment (intent to treat)• Non-randomized component will use

initially chosen treatment (pseudo-intent to treat)


Analysis Plan (cont’d)

Initial analysis will use pooled data from both components

• Use multivariate linear regression model• Include parameters for potential

confounders• Include parameter for study component

(randomized vs. non-randomized)


Analysis Plan (cont’d)

Assess bias in treatment group (surgical vs. non-surgical) between components (randomized vs. non-randomized)• No evidence of residual bias after controlling

for potential confounders?– Use pooled data for primary analysis

• Evidence of residual bias?– Report on both components– Use randomized data only for primary

analysis


S1316 – MBO StudyRecruitment Materials & Resources

• Professional Slide Set• Patient Brochure

Resources:• S1316 webpage -

http://swog.org/Visitors/S1316/Index.asp• S1316 Working Group: [email protected] • Conference calls


http://swog.org/Visitors/S1316/Index.asp

mailto:[email protected]

S1316 – MBO StudyParticipating Study Sites


University of ArizonaSetsuko K. Chambers, MD (Gyn Onc)Valentine Nfonsam, MD (Colorectal Surg)

Duke UniversityAmy P. Abernethy, MD (Med Onc/HPM)Paul J. Mosca, MD, PhD (Surg Onc)Angeles Secord, MD (Gyn Onc)

MD Anderson Cancer CenterBrian D. Badgwell, MD, MS (Surg Onc)Richard Royal, MD (Surg Onc)Robert Coleman, MD (Gyn Onc)Larissa Meyer, MD (Gyn Onc)George Chang, MD (Surg Onc)Karen Lu, MD (Gyn Onc)

City of Hope Cancer CenterBetty Ferrell, PhD, MA (Nursing Research)Ernest Han, MD (Gyn Onc)Gagandeep Singh, MD (Surg Onc)Yuman Fong, MD (Surg Onc)

University of MichiganPhillip E. Rodgers, MD (HPM)Samantha Hendren, MD (Colorectal Surg )Kevin Reynolds, MD (Gyn Onc)

Memorial Sloan-Kettering Cancer CenterDennis Chi, MD (Gyn Onc)Nadeem Abu-Rustum, MD (Gyn Onc)Ginger Gardner, MD (Gyn Onc)Larissa K. F. Temple, MD (Colorectal Surg)

Thank You


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